Tarlov CystsARCSTSCCNCT04465305
A Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal Reinforcement
A study testing entraped treatment and plasty treatment in people with Tarlov Cysts, run by Peking University Third Hospital at 1 site in China.
Trial summary
The subject will treat 68 patients with symptomatic sacral canal cysts as the research object, and adopt a randomized controlled research method, respectively, using two methods of reinforcement and reconstruction of the nerve root sleeve, sacroplasty and nerve root sleeve plasty, and observed the operation of the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tarlov Cysts
- What is being tested?
- entraped treatment and plasty treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic nerve root cysts diagnosed by MRI
- Intact cyst capsule, no defect of sacral canal lamina
- No other diseases of nervous system, pelvic floor and important organs
- Agree inclusion
Who cannot join
- a ) Non-radiculent cysts or asymptomatic cysts b) Cysts cause severe bone erosion to lamina resorption c) Combined with other diseases of nervous system, pelvic floor and important organs d) Disagree to join e) Cannot complete follow-up -
Trial locations and contacts
1 site in 1 country.
wu chao contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Haidian, 100191
liu bin, 13671027688, liubin301@163.com
About this study
Official title: A Randomized Controlled Study of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canopy for the Treatment of Sacral Canal Cysts
The subject will treat 68 patients with symptomatic sacral canal cysts as the research object, and adopt a randomized controlled research method, respectively, using two methods of reinforcement and reconstruction of the nerve root sleeve, sacroplasty and nerve root sleeve plasty, and observed the operation of the patient Complications, preoperative and postoperative short-term and long-term VAS pain scores, JOA neural function scores, and changes in cyst size on imaging examinations, to evaluate the safety of nerve root sleeve reconstruction and sacroplasty in reducing the safety of postoperative cyst recurrence Sex and effectiveness, so as to further improve the surgical treatment of sacral canal cysts, improve the curative effect, and formulate the operation specifications for the treatment of sacral canal cyst
Read the detailed description
In this subject, a cohort observation method was used to observe 52 patients with two types of surgical removal of hematoma in the basal ganglia under the guidance of frontal ultrasound through keyhole neuroendoscopy and microsurgery for hematoma removal under the guidance of frontal ultrasound. They were divided into endoscopic surgery group and microsurgery. In the endoscopic surgery group, 26 cases were treated with keyhole neuroendoscopy under the guidance of frontal ultrasound for hematoma removal in the basal ganglia area, and 26 cases in the microsurgery group were treated by craniotomy microsurgery hematoma removal surgery. Observe the removal rate of surgical hematoma in the two groups And the safety of the operation and the GCS score, GOS score and MRI examination of nerve fiber damage and postoperative complications at 1 week, 1 month, and 3 months after the operation. Observe and analyze the improvement of the hematoma clearance rate in the endoscopic surgery group. And whether it has an advantage in terms of efficacy
- Conditions
- Tarlov Cysts
- Being tested
- entraped treatment, plasty treatment
- Keywords
- tarlov cysts surgery
- Medical subject headings
- Tarlov Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
entraped treatmentProcedure or surgery
Also called plasty treatment
patients with tarlov cysts treated by entraped and plasty nerve root
plasty treatmentProcedure or surgery
patients with tarlov cysts treated by plasty nerve root
| Study group | Role | What they receive |
|---|---|---|
| enraped group | Experimental | patients with a new treatment of tarlov cysts Receives: Procedure: entraped treatment; Procedure: plasty treatment |
| plasty group | Active comparator | patients with traditional treatment of tarlov cysts Receives: Procedure: plasty treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent rate of tarlov cysts
patents who recurrent postoperation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tarlov CystsStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Sponsor
- Investigators
- liu bin, Study chair, Peking University Third Hospitalwang zhenyu, Study director, Peking University Third Hospitalxie jinchen, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465305
- Sponsor's protocol ID
- PekingUTHNSD
- Acronym
- ARCSTSCC
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Nerve Root Sleeve Reinforcement and Reconstruction and Sacral Canopy for the Treatment of Sacral Canal Cysts
- ClinicalTrials.gov ID
- NCT04465305
- Acronym / sponsor ID
- ARCSTSCC / PekingUTHNSD
- Conditions
- Tarlov Cysts
- Keywords
- tarlov cysts surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The subject will treat 68 patients with symptomatic sacral canal cysts as the research object, and adopt a randomized controlled research method, respectively, using two methods of reinforcement and reconstruction of the nerve root sleeve, sacroplasty and nerve root sleeve plasty, and observed the operation of the patient Complications, preoperative and postoperative short-term and long-term VAS pain scores, JOA neural function scores, and changes in cyst size on imaging examinations, to evaluate the safety of nerve root sleeve reconstruction and sacroplasty in reducing the safety of postoperative cyst recurrence Sex and effectiveness, so as to further improve the surgical treatment of sacral canal cysts, improve the curative effect, and formulate the operation specifications for the treatment of sacral canal cyst
Detailed description
In this subject, a cohort observation method was used to observe 52 patients with two types of surgical removal of hematoma in the basal ganglia under the guidance of frontal ultrasound through keyhole neuroendoscopy and microsurgery for hematoma removal under the guidance of frontal ultrasound. They were divided into endoscopic surgery group and microsurgery. In the endoscopic surgery group, 26 cases were treated with keyhole neuroendoscopy under the guidance of frontal ultrasound for hematoma removal in the basal ganglia area, and 26 cases in the microsurgery group were treated by craniotomy microsurgery hematoma removal surgery. Observe the removal rate of surgical hematoma in the two groups And the safety of the operation and the GCS score, GOS score and MRI examination of nerve fiber damage and postoperative complications at 1 week, 1 month, and 3 months after the operation. Observe and analyze the improvement of the hematoma clearance rate in the endoscopic surgery group. And whether it has an advantage in terms of efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enraped group | Experimental | Procedure: entraped treatment, Procedure: plasty treatmentpatients with a new treatment of tarlov cysts |
| plasty group | Active comparator | Procedure: plasty treatmentpatients with traditional treatment of tarlov cysts |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic nerve root cysts diagnosed by MRI
- Intact cyst capsule, no defect of sacral canal lamina
- No other diseases of nervous system, pelvic floor and important organs
- Agree inclusion
Key exclusion criteria (1 listed)
- a ) Non-radiculent cysts or asymptomatic cysts b) Cysts cause severe bone erosion to lamina resorption c) Combined with other diseases of nervous system, pelvic floor and important organs d) Disagree to join e) Cannot complete follow-up -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| entraped treatmentAlso: plasty treatmentpatients with tarlov cysts treated by entraped and plasty nerve root | Procedure or surgery | enraped group |
| plasty treatmentpatients with tarlov cysts treated by plasty nerve root | Procedure or surgery | enraped group, plasty group |
Primary outcome
recurrent rate of tarlov cysts
Time frame: 1 year
patents who recurrent postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Tarlov Cysts
Not yet recruitingObservational study
Long-Term Outcomes of Different Surgical Techniques for Sacral Tarlov Cysts: A Prospective Cohort Study
Sacral Tarlov Cysts, Symptomatic Sacral Cysts
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wu chao contact
liu bin study chair
Peking University Third Hospital
wang zhenyu study director
Peking University Third Hospital
xie jinchen principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing entraped treatment and plasty treatment in people with Tarlov Cysts, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact liu bin (13671027688, liubin301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent rate of tarlov cysts (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.